Quality Engineer

Description : OVERVIEW

The Quality Engineer 1 is responsible for the design, development, and sustaining of quality processes and inspection methods, including procedures, gauging, programming, and documentation. This individual works with Quality Control, Product Development, and Manufacturing Operations Departments to support daily production, projects, and site initiatives. This individual is responsible for maintaining compliance of the quality system to internal and external medical device industry standards and regulation. This individual must have an eagerness to learn, understanding of manufacturing and quality principles, strong communication skills, technical proficiency in common software systems (Word, Excel, etc.), and a keen attention to detail. Experience in statistical analysis and / or software development and familiarity with Tulip, Jira, and Agile methodology is strongly preferred.

RESPONSIBILITIES

• Develops various inspection techniques and procedures to ensure product integrity to design specifications.
• Responsible for the writing, approval and implementation of Receiving, Floor and final Inspection procedures and operator self-inspection procedures.
• Works with other Quality Engineers and the Metrology Lab personnel on the development and procurement of product gauging, optical comparator overlays, and templates.
• Coordinates and executes the development of quality processes, which may include work instructions, procedures, gauges, overlays, test methods, etc.
• Trains Manufacturing Associates in measuring, testing and inspection techniques.
• Performs first article inspections, capability studies, process validations, and metallurgical analyses as necessary to characterize products, processes and materials.
• Works with suppliers, engineers, and manufacturing associates in the resolution of quality problems, which may involve work on NCRs, material dispositions, compiling, trending, and analyzing quality data, and presentation of feedback to internal customers and external vendors suppliers.

EXPERIENCE AND REQUIREMENTS

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